Status:

COMPLETED

Cardiovascular Analysis of PEM

Lead Sponsor:

Icahn School of Medicine at Mount Sinai

Collaborating Sponsors:

National Institute of Neurological Disorders and Stroke (NINDS)

Conditions:

Myalgic Encephalomyelitis

Chronic Fatigue Syndrome

Eligibility:

All Genders

25-60 years

Phase:

NA

Brief Summary

The purpose of this study is to examine cardiopulmonary function in Chronic Fatigue Syndrome (CFS) patients and determine how it relates to the common symptom of Post-exertional malaise (PEM). Subject...

Eligibility Criteria

Inclusion

  • Ages 25 to 60
  • Meet the 2015 IOM case definition for ME/CFS

Exclusion

  • Patients with a medical cause for their fatigue
  • Patients taking medications that would dampen cardiac response to exercise
  • Patients with psychotic illness, bipolar disorder, or current major depressive disorder
  • Patients with a history of anorexia or bulimia within 5 years of intake
  • Patients with a history of alcohol or drug abuse within 2 years of intake

Key Trial Info

Start Date :

August 31 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 11 2025

Estimated Enrollment :

106 Patients enrolled

Trial Details

Trial ID

NCT04740736

Start Date

August 31 2021

End Date

July 11 2025

Last Update

December 18 2025

Active Locations (1)

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Icahn School of Medicine at Mount Sinai

New York, New York, United States, 10029